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Trial Title:
Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
NCT ID:
NCT05930665
Condition:
Pleural Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Bevacizumab
Carboplatin
Pemetrexed
Conditions: Keywords:
bispecific antibody
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Description:
Cadonilimab 10mg/kg intravenous (IV) every 3 weeks + Bevacizumab 7.5mg/kg IV every 3
weeks + Pemetrexed 500 mg/m² IV every 3 weeks + Carboplatin AUC 5 IV every 3 weeks for 4
to 6 cycles, followed by maintenance with Cadonilimab 10mg/kg IV every 3 weeks +
Bevacizumab 7.5mg/kg IV every 3 weeks
Arm group label:
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Other name:
AK104
Summary:
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to
retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety
profile of the combination therapy. The aim of this study is to evaluate the efficacy and
safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first
Line therapy in unresectable pleural mesothelioma.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Histologically confirmed pleural malignant mesothelioma not eligible for curative
surgery
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3. No previous systemic anti-tumor treatment for advanced/metastatic disease
4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant
pleural mesothelioma.
5. Adequate haematological, renal and liver function.
Key Exclusion Criteria:
1. Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma.
2. Active, untreated central nervous system (CNS) metastasis.
3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor
indications within 14 days prior to the first dose of study treatment.
4. Known active autoimmune diseases.
5. Presence of other uncontrolled serious medical conditions.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenfeng Fang, MD
Phone:
+86-15322302066
Email:
fangwf@sysucc.org.cn
Start date:
November 1, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05930665
